Cultural-Linguistic Considerations for Successful Cognitive Endpoint Assessment in International CNS Clinical Trials

Expert Contributions from Global Clinicians

Cognitive assessment is a powerful tool to illuminate the effects of investigational therapies in central nervous system (CNS) diseases. Tests of cognitive functioning, however, are nuanced and complex. They require high clinical skills and hands-on assessment experience to achieve proper administration. In addition, considerable cultural bias — inherent to traditional cognitive assessment — complicates the deployment of cognitive tests in global clinical trials. Since cognitive scales are mostly developed for use in English-speaking, Western contexts, the use of translated tests with patients in other cultural-linguistic groups can be problematic.

Gathering valid and reliable data from cognitive testing in international, multi-country clinical trials requires the expert oversight of highly specialized clinicians. These clinicians should be well-versed in the complexities of cognitive assessment and have native-level awareness of the cultural-linguistic context in testing. Specialized clinician teams of Local Expert Advisors, sometimes referred to as “LEADs,” should be retained and utilized throughout the lifecycle of clinical research studies involving cognition. LEADs can provide expert input for scale selection and translation, training of site raters, formal evaluation of raters’ skills mastery with real-time feedback and much more. In decentralized trial formats — or studies involving particularly complex scales — LEADs may take on the role of clinical raters and directly deliver cognitive assessments to study subjects.

Appropriate utilization of clinical and linguistic experts helps ensure high-quality data is gathered from cognitive assessments in global trials. In this webinar, the featured speaker from Cogstate will share hands-on experiences and best practices for global trials.

Join this webinar to learn the considerations for successful cognitive assessment in global trials and share how clinical trial teams can benefit from local expert clinicians supporting their CNS research.

Speaker

Svenja Wacker, PhD, Science Director, Business Development, Cogstate

Svenja Wacker, PhD is a bilingual (German/English), licensed clinical neuropsychologist with expertise in global clinical trial management and consultation, as well as extensive experience in hospital-based rehabilitation neuropsychology, neuropsychological assessment and intervention, program development and medical staff training. She serves as Science Director on Cogstate’s Business Development team.

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